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U.S. Department of Health and Human Services

Class 2 Device Recall PIC050 Arterial Blood Sampler

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  Class 2 Device Recall PIC050 Arterial Blood Sampler see related information
Date Initiated by Firm April 08, 2022
Create Date May 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-1115-2022
Recall Event ID 90093
510(K)Number K962158  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
Code Information "All Lots" UDI/DI: 05700699565525
Recalling Firm/
Manufacturer		 Radiometer Medical ApS
Akandevej 21
Bronshoj Denmark
Manufacturer Reason
for Recall		 Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
FDA Determined
Cause 2		 Package design/selection
Action On April 26, 2022 Radiometer issued a "Urgent Medical Device Recall" notification via Email. The firm ask consignees to take the following actions: Radiometer kindly request you to stop using the affected product with immediate effect. To ensure patient safety in your facility, kindly follow the steps below: " Check your inventory of the above PICO50 Arterial Blood Samplers " Check for the above PICO50 Arterial Blood Samplers distributed in your institution. " Collect any of the above PICO50 Arterial Blood Samplers and put on quarantine " Complete the Recall Response Form (last page of this letter) and return to your Radiometer representative together with the quarantined PICO50 Arterial Blood Samplers. To ensure you receive credit for the PICO50 Arterial Blood Samplers, please contact Customer Service @ CSRsupport@radiometeramerica.com to receive a Return Goods Authorization
Quantity in Commerce 7,228 boxes (100 units per box)
Distribution Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DC, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, TN, TX, WA, WI and the countries of Canada, Italy, Norway, Austria, Algeria, Argentina, Bolivia, Bosnia, Brazil, Burkina, Faso, Chile, Colombia, Cyprus, Ecuador, Egypt, Eswatin, Ethiopia, Greece, Guatemala, Israel, Lebanon, Libya, Lithuania, Malawi, Nicaragua, Romania, Senegal, Serbia, Slovenia, Thailand, Uganda, Uruguay, Vietnam, Zimbabwe, Belgium, Netherlands, China, Macao, Croatia, Hungary, Denmark, Iceland, Germany, Spain, Portugal, India, Japan, United Kingdom, Ireland, Russia, Australia, Switzerland, France, Czech Republic, Slovakia, South Africa, Botswana, Namibia, Poland, Turkey, Georgia, Sweden, Finland, Estonia, Kazakhstan, Malaysia, Hong Kong.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = RADIOMETER AMERICA, INC.
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